BETAMETASONE 0.05% Cream

Зміст інструкції

1. Betametasone dipropionato Sandoz 50mg/100g cream
   1. What Betametasone dipropionate Sandoz is and what it is used for
   2. What you need to know before using Betametasone dipropionate Sandoz
   3. How to use Betametasone dipropionato Sandoz
   4. Possible side effects
   5. How to store Betametasone dipropionato Sandoz
   6. Contents of the pack and other information

Betametasone dipropionato Sandoz 50mg/100g cream

Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Betametasone dipropionato Sandoz is and what it is used for
• 2. What you need to know before you use Betametasone dipropionato Sandoz
• 3. How to use Betametasone dipropionato Sandoz
• 4. Possible side effects
• 5. How to store Betametasone dipropionato Sandoz
• 6. Contents of the pack and other information

1. What Betametasone dipropionate Sandoz is and what it is used for

Betametasone dipropionato Sandoz is a cream for topical application containing the active ingredient
betametasone dipropionate, which belongs to a group of medicines called corticosteroids, used
to treat inflammation and allergies.
Betametasone dipropionato Sandoz is indicated for skin inflammations and in particular for
those located in areas where the skin is thinner and more delicate:

• skin inflammations caused by external factors such as contact eczema caused by detergents or cosmetics or directly related to the working environment (occupational irritations);
• inflammatory skin reactions (eczema) of various types (constitutional, stasis);
• seborrheic eczema, an inflammation of the skin that mainly affects areas rich in sebaceous glands such as the scalp, ear and face, in both adults and children (cradle cap);
• irritation with the appearance of blisters on the hands and feet (dyshidrosis);
• skin inflammation caused by generalized itching, anal and genital areas;
• inflammation of the skin caused by continuous friction of two parts of the body (intertrigo);
• sunburn, an inflammatory skin reaction caused by exposure to sunlight;
• irritations caused by allergies to plants, chemicals or insect bites;
• psoriasis, a chronic inflammatory skin disease involving the immune system and other inflammatory skin diseases ( lichen simplex of Vidal-Brocq, lichen ruber planus).

2. What you need to know before using Betametasone dipropionate Sandoz

Do not use Betametasone dipropionate Sandoz

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you have a type of skin infection called cutaneous tuberculosis or other untreated infections;
• if you have a skin infection caused by viruses (herpes simplex, varicella);
• if you have a skin infection caused by fungi or bacteria;
• if you suffer from rosacea, a skin disease characterized by irritation and redness on the face;
• if you have acne vulgaris, an inflammation of the skin with the appearance of pimples;
• if you have inflammation around the mouth (perioral dermatitis);
• to treat itching without inflammation;
• itching in the genital and anal area (perianal and genital pruritus);
• if you have skin lesions (skin ulcers) or lesions infected by fungi or bacteria;
• if the person who needs to use this medicine is a child under 1 year of age, even in case of dermatitis and diaper rash.

Do not apply an occlusive bandage to infected skin or skin with exudative lesions.

Warnings and precautions
Consult your doctor or pharmacist before using Betametasone dipropionate Sandoz.
Betametasone dipropionate Sandoz must not be applied to the eyes.
Use this medicine with cautionand inform your doctor in the following cases:

• if you are elderly, in this case you should use the lowest possible dose;
• if you have liver or kidney problems (renal or hepatic insufficiency), in this case you should use the lowest possible dose;
• if you need to apply the medicine using an occlusive bandage;
• if you suffer from a skin disease called psoriasis;
• if you need to apply the cream to the face or eyelids, to avoid contact with the eyes.

Avoid long-term treatment and with high doses, because absorption through the skin (systemic absorption) can occur.
This is even more likely to happen if the cream is applied under an occlusive (non-breathable) bandage or under a baby's diaper, or if you apply the medicine to skin with lesions or in areas where the skin is thin, such as the face.
If you are using the medicine for the treatment of dermatitis near ulcers, you may more frequently develop hypersensitivity reactions and local infections.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) following the use of this medicine, especially for prolonged periods. Prolonged and repeated use can make you more prone to developing bacterial, viral or fungal skin infections. If you have skin infections, use this medicine together with another medicine against fungi (antifungal) or bacteria (antibacterial). If you do not notice any improvement, consult your doctor who will tell you to stop treatment and will administer appropriate therapy.
To avoid the onset of side effects caused by an excess of corticosteroids, it is good practice to use the lowest dose necessary to control the symptoms of the disease and for the shortest time possible. If you experience undesirable effects due to the influence of the active ingredient on the glands of the body (Cushing's syndrome, reversible suppression of the hypothalamus-pituitary-adrenal axis), consult your doctor who will tell you to gradually discontinue the use of the medicine or prescribe a less potent corticosteroid.

Children
Administer the medicine to children only when absolutely necessary, and under strict medical supervision, because it may increase the risk of undesirable effects due to greater absorption of the active ingredient, especially in infants (see section 4 “Possible side effects”). The use of the medicine in children should not exceed 5 days of treatment, using the minimum amount and avoiding the application of an occlusive bandage, including the use of diapers in infants.

Other medicines and Betametasone dipropionate Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Use Betametasone dipropionate Sandoz with caution and inform your doctor if you are using certain medicines that alter the metabolism of betamethasone, such as itraconazole, a medicine used for fungal infections, or ritonavir, used to treat HIV.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary and under the direct supervision of your doctor.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.

Betametasone dipropionate Sandoz containscetostearyl alcohol, parabens and propylene glycol
This medicine contains cetostearyl alcohol which may cause local skin reactions (for example contact dermatitis).
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (also delayed).
This medicine contains propylene glycol which may cause skin irritation.

3. How to use Betametasone dipropionato Sandoz

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, ask your doctor or pharmacist.
Betametasone dipropionato Sandoz should NOT be applied to the eyes.
Apply the cream 1 or 2 times a day to the affected area and massage gently to promote
absorption.

If you use more Betametasone dipropionato Sandoz than you should
In case of ingestion/accidental intake of Betametasone dipropionato Sandoz, contact
your doctor immediately or go to the nearest hospital.
Excessive or prolonged use of this medicine can cause undesirable effects due to
corticosteroids such as: adrenal gland dysfunction and increased levels of steroids
in the body (hyperadrenalism). These symptoms may disappear after stopping the
treatment, reducing the frequency of application or replacing it with another similar medicine.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Prolonged use and/or high doses can induce an excess syndrome that manifests with the following
symptoms:

• increase in blood pressure (arterial hypertension);
• loss of muscle strength (asthenia, adynamia);
• irregular heartbeat (cardiac rhythm disturbances);
• reduction of potassium levels in the blood (hypokalaemia) and increase in blood pH (metabolic alkalosis).

The following side effects may occur:

Common(may affect up to 1 in 10 people):

• burning and pain of the skin;
• itching.

Very rare(may affect up to 1 in 10,000 people):

• allergic reactions;
• infections that occur following a weakening of the immune defenses (opportunistic infections);
• thinning of the skin (atrophy) and stretch marks (striae), dry skin;
• dilation of superficial capillaries (telangiectasia) and changes in skin color;
• increased hair growth (hypertrichosis);
• skin irritations (allergic contact dermatitis/dermatitis, erythema, rash, urticaria);
• skin inflammation with the formation of pustules (pustular psoriasis)
• wrinkling of the skin
• worsening of existing symptoms;
• irritation and pain in the application area;
• increased amount of cortisol in the blood, with consequent inhibition of its release system by the adrenal gland (suppression of the hypothalamus-pituitary-adrenal axis) which manifests with characteristic symptoms such as: obesity in the central part of the body and moon face (Cushing's syndrome), delayed growth in children, bone problems (osteoporosis), eye diseases (glaucoma, cataract), increased levels of sugar in the blood and urine (hyperglycaemia/glycosuria), increased blood pressure (hypertension), hair loss (alopecia), weight gain, hair fragility (trichorrhexis). These effects are more frequent in children and following prolonged use or on extensive areas or following the application of a non-breathable bandage (occlusive bandage) or the diaper. Not known(frequency cannot be defined based on available data):
• redness, swelling (edema), scaling;
• itching with signs of hypersensitivity to the product;
• skin inflammation similar to acne (acneiform eruptions);
• fragility of blood vessels, red spots caused by the rupture of blood vessels (purpura), which occur more frequently on the face after prolonged treatments;
• skin irritation and formation of pustules (rebound pustular dermatitis) which occur when treatment is stopped.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety
of this medicine.

5. How to store Betametasone dipropionato Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Betametasone dipropionate Sandoz contains

• The active ingredient is betamethasone dipropionate. Each 100 g of cream contains 0.05 g of betamethasone dipropionate.
• The other ingredients are: purified water; cetostearyl alcohol; glycerin; petrolatum oil; emulgade 1000 NI; propylene glycol; methylparaben; propylparaben.

Description of the appearance of Betametasone dipropionate Sandoz and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA) – Italy

Manufacturer
Mipharm S.p.A. – Via B. Quaranta, 12 – 20141, Milan – Italy